Irbesartan

As a first-line antihypertensive drug commonly used in clinical practice, irbesartan belongs to the angiotensin Ⅱ receptor antagonist (ARB) class. It highly selectively blocks the type 1 receptor of angiotensin Ⅱ, inhibits vasoconstriction and aldosterone release, thereby steadily lowering blood pressure. Meanwhile, it can reduce renal proteinuria and delay myocardial remodeling. In addition to essential hypertension, it is also indicated for patients with type 2 diabetic nephropathy and left ventricular hypertrophy complicated by hypertension. It is a common treatment option with both antihypertensive and target organ protective effects, with good long-term medication tolerance and low incidence of adverse reactions.

Currently, the global market size of irbesartan is approximately USD 1.3 billion, while the market size in China exceeds RMB 2.5 billion. With the rising prevalence of hypertension and the release of long-term medication demand for chronic diseases, the compound annual growth rate of the market in the past three years has maintained at around 4.2%. In terms of the competitive landscape, generic drugs dominate the market after the patent expiration of this drug. More than 30 domestic enterprises have obtained approval for irbesartan preparations, among which 7 product specifications are included in the national centralized procurement. The highest price reduction of the winning bids compared with the original research drug reaches 90%. The supply of API is mainly dominated by domestic enterprises, with sufficient overall supply and high industry concentration.

The original research enterprise of irbesartan is Sanofi, and the original brand name is "Aprovel". The core compound patent expired in Europe and the United States in 2011, and the core patent in China expired in 2012. The main dosage form of the original research drug is tablet, with common specifications including 75mg, 150mg and 300mg, which have been included in the *Catalogue of Chemical Reference Preparations* of China and the FDA Reference Preparations Catalogue. Up to now, there are more than 40 irbesartan API registration information on China's CDE API Registration Platform, among which more than 25 are in status A (approved for use in marketed preparations). A number of preparation varieties such as irbesartan tablets and irbesartan hydrochlorothiazide tablets have been approved for marketing in China. (Data as of June 2025, please refer to the official CDE website for the latest information)

CATO can provide a full set of impurity reference standards for irbesartan API. Most products are in stock. For in-stock products, orders placed before 16:00 will be shipped on the same day. Meanwhile, the products meet the compliance requirements of multiple regulations such as Chinese Pharmacopoeia and FDA, and can fully meet the R&D and production needs of pharmaceutical enterprises in different scenarios such as impurity research and quality control.